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  • Writer's pictureShannon Lantzy

FDA IT: Instead of "Pilot," maybe "Trial?" (Plus: FDA IT Modernization Comments Due next month)

FDA doesn't like "pilots." Instead, should they run IT "trials?"


FDA, like most of the government, needs better IT. They're working on it. It would come as no surprise to my readers that I support giving FDAers all the IT they need to do their jobs well because their jobs affect all the humans I know. But, I also believe that when it comes to regulatory decisions, IT should be adopted slowly and based on evidence that the IT change will have a positive outcome on users' work.


FDA's Request for Comments on IT Modernization (a PDUFA commitment)

No one needs better IT more than FDA reviewers. Their job is hard, extremely important, and onerous. We should all want to make their lives easier. Not surprisingly, they're sometimes allergic to "help." Contractors, consultants, policy leaders, external "experts" all have lots of suggestions for helping reviewers, but often the help doesn't actually help them do their job. Worse, it may slow them down.


In the IT delivery world, it's common to run a "pilot" before implementing a large change. Pilots are important to test the IT for positive outcomes and disruption. But there are Too. Many. Endless. Pilots. And (in my humble opinion and personal experience) pilots are usually not designed to effectively evaluate outcomes. They're tests to work out the kinks, but not to confirm the expected value from the IT.


Instead of pilots, maybe IT innovators should design and run trials. Does the new technology or process actually improve the outcomes it is intended to improve (in the case of FDA reviewers, good regulatory actions)? Does the technology provider actually have any idea what outcomes are needed for the user population? (Okay, maybe that's a little harsh, but having been naive once or twice in my life, wink wink, I will admit I personally have hawked ideas toward NASA executives and FDAers that I realize in hindsight were a bit sophomoric due to me insufficient understanding of the regulatory review workflow. I'm a bit more humble now, if only a bit.)


~Shannon, the Optimistic Optimizer


Ps. If you care about FDA IT, there's a docket open for public comment: https://www.federalregister.gov/documents/2023/09/19/2023-20136/food-and-drug-administration-information-technology-strategy-request-for-comments

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